Integrated wire embedding tool and preparation and assembly method thereof

Abstract

The invention relates to an integrated catgut embedding tool which is characterized by comprising a handle, a needle tube and a degradable embedded catgut. A containing space is formed in the needle tube, one end of the needle tube is connected with the handle, and a needle tip and a needle tip opening communicated with the containing space are arranged at the other end of the needle tube. One end of the degradation embedded line is inserted into the accommodating space of the needle tube through the needle tip opening, and the other end of the degradation embedded line is arranged outside the needle tube and is bent towards the direction of the handle to form a bent part; the needle tube penetrates through the fixer, the fixer wraps the degradation embedded line on the outer wall of the needle tube, the degradation embedded line is made of magnesium or magnesium alloy materials, and the degradation embedded line is formed by extruding a cast ingot and then rolling or drawing. In the assembling process, one end of the degradation embedded line is inserted into the needle tube, the needle tube penetrates through the fixator, and the other end of the degradation embedded line is wrapped on the outer side of the needle tube by the fixator.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine acupuncture and moxibustion, and more specifically to an integrated catgut embedding tool and its preparation and assembly methods. Background Art

[0002] In traditional Chinese medicine acupoint catgut embedding, under the guidance of the acupuncture and meridian system, tools such as injection needles, disposable catgut embedding needles, etc. are used to place catgut threads with a length of 1 - 3 cm or absorbable threads such as PGA and PDS in the corresponding acupoint areas. Through the gentle, slow, long-term, and beneficial acupoint needle sensation stimulation effect, it achieves the function of dredging the meridian qi and preventing and treating diseases.

[0003] In clinical treatment, embedding tools such as injection needles, disposable catgut embedding needles, and spring needles need to cut the catgut embedding into the required length in advance and then load it into the needle, which increases the complexity of clinical operations. Existing patents have improved the structure of the catgut embedding needle. For example, storage grooves, storage chambers, clip-type feeding mechanisms, etc. are used to achieve automatic threading, or cutting mechanisms are used to achieve automatic wire breaking. However, in actual operation, the improved catgut embedding needle increases the product volume and is more troublesome in acupoint catgut embedding techniques compared to traditional disposable catgut embedding needles and injection needles.

[0004] On the other hand, existing catgut threads have a relatively large foreign body reaction, while high-molecular absorbable catgut embeddings such as PGA and PDS have aseptic inflammatory reactions, manifested as problems such as local temperature rise, redness, swelling, pain, and exudation in the early stage of embedding; the catgut embedding is a single-strand or multi-strand braided wire, with a risk of displacement in the body and even exposure on the body surface; the absorbable catgut embedding has a long absorption period, with the fastest absorption in 50 - 70 days and the slowest taking more than 6 months to be completely absorbed. And the treatment cycle of acupoint catgut embedding is 7 days to 1 month, and the existing absorbable catgut embeddings in this treatment cycle are difficult to be completely degraded and absorbed.

[0005] In contrast, magnesium metal has good biocompatibility after being implanted into the human body. Magnesium metal can react with body fluids in the human body environment, and the degradation products are magnesium hydroxide and hydrogen; among them, magnesium hydroxide can ionize into magnesium ions and hydroxide ions, forming an alkaline degradation environment, avoiding the occurrence of aseptic inflammation; and the magnesium ions produced by degradation have an analgesic effect. The degradation product hydrogen is a bioactive reducing small molecule gas, with functions such as selective antioxidant, anti-inflammatory, inhibiting apoptosis, and regulating gene expression. It is more suitable as a raw material for acupoint catgut embedding. Summary of the Invention

[0006] In view of the above problems, the present invention provides an integrated catgut embedding tool that does not require threading.

[0007] An integrated catgut embedding tool, characterized by comprising:

[0008] A handle;

[0009] A syringe with an accommodation space inside. One end of the syringe is connected to the handle, and the other end is provided with a needle tip and a needle tip opening communicating with the accommodation space;

[0010] A degradable buried wire made of magnesium or magnesium alloy. One end of the degradable buried wire is inserted into the accommodation space of the syringe through the needle tip opening, and the other end of the degradable buried wire is placed outside the syringe;

[0011] A fixator. The syringe passes through the fixator, and the fixator wraps the fixing part of the degradable buried wire on the outer wall of the syringe;

[0012] Furthermore, for the integrated buried wire tool as described above, a bending part is formed at the needle tip opening of the degradable buried wire. The bending part is arc-shaped with a diameter of 0.05 - 0.5 mm.

[0013] Furthermore, for the integrated buried wire tool as described above, the width of the degradable buried wire is 0.1 - 0.3 mm, and the thickness is 0.1 - 0.3 mm.

[0014] Furthermore, for the integrated buried wire tool as described above, the part of the degradable buried wire placed outside the syringe accounts for 30% - 50% of the total length of the degradable buried wire.

[0015] Furthermore, for the integrated buried wire tool as described above, the fixator is made of a polymer material with a Shore hardness A of 10 - 40. Its length along the syringe direction is 3 mm - 10 mm, and the diameter is not less than 2 mm - 5 mm.

[0016] Furthermore, for the integrated buried wire tool as described above, barbs are provided on the surface of the degradable buried wire.

[0017] Furthermore, for the integrated buried wire tool as described above, the degradation rate of the degradable buried wire is greater than or equal to 1.5 mm / year and less than or equal to 10 mm / year.

[0018] Even further, for the integrated buried wire tool as described above, the tensile strength of the degradable buried wire is greater than or equal to 150 MPa and less than or equal to 300 MPa, the yield strength is greater than or equal to 80 MPa and less than or equal to 250 MPa, the elongation after fracture is greater than or equal to 5%, the reduction of area is greater than or equal to 5%, and the hardness is less than or equal to 60 HV0.1.

[0019] The present invention also provides a preparation method for the degradable buried wire in the above integrated buried wire tool, which is characterized by including:

[0020] Extruding an ingot, extruding a magnesium or magnesium alloy ingot with an impurity content less than or equal to 0.1% into a plate with a thickness not exceeding 4 mm and a width not exceeding 120 mm;

[0021] Roll forming: Through the isothermal online heating rolling method, it is rolled into a thin plate with a thickness of 0.1 - 0.3 mm in 8 - 16 passes, and after full annealing at 300°C - 350°C, it is made into a strip-shaped degradable buried wire with a width of 0.1 - 0.3 mm, a thickness of 0.1 - 0.3 mm, and a length of 1 - 10 cm by laser cutting or die stamping.

[0022] Furthermore, in the preparation method as described above, it is characterized in that the mass fraction of alloying elements in the magnesium alloy is 0 - 3%.

[0023] The present invention also provides another preparation method for the degradable buried wire in the above-mentioned integrated buried wire tool, which is characterized by including:

[0024] Extrusion ingot: Extrude a magnesium or magnesium alloy ingot with an impurity content less than or equal to 0.1% into a wire with a diameter not exceeding 2 mm.

[0025] Drawing fine wire: Through more than 40 passes of drawing and intermediate annealing treatment, a buried wire fine wire with a diameter of 0.05 - 0.3 mm is obtained.

[0026] Buried wire forming: Clean, cut, and form at least one of the above-mentioned buried wire fine wires, and finally form a filamentous degradable buried wire with a length of 1 - 10 cm and a cross-sectional diameter of 0.1 - 0.3 mm.

[0027] Further, in the preparation method as described above, in the buried wire forming stage, two or more of the above-mentioned washed and cut buried wire fine wires are wound or braided to form a filamentous degradable buried wire with a length of 1 - 10 cm and a cross-sectional diameter of 0.1 - 0.3 mm.

[0028] Furthermore, in the preparation method as described above, the mass fraction of alloying elements in the magnesium alloy is 0 - 3%.

[0029] In addition, the present invention discloses an assembly method for the above-mentioned integrated buried wire tool, which is characterized by including:

[0030] Install the needle tube: Insert the end of the needle tube away from the needle tip into the handle.

[0031] Insert the degradable buried wire: Insert one end of the degradable buried wire into the accommodation space of the needle tube through the opening of the needle tip, and pre-bend the other end of the degradable buried wire towards the handle to form a pre-bent portion.

[0032] The fixator is installed, and the needle tip of the needle tube is inserted from the insertion end of the fixator and passed out from the exit end of the fixator, and the insertion end and the exit end are correspondingly arranged; the fixator wraps the degradable embedded thread on the outer wall of the needle tube, and the pre-bent portion passes out from the exit end of the fixator to form the bent portion.

[0033] Furthermore, in the assembly method as described above, the puncture resistance of the needle tube equipped with the degradable embedded suture when passing through the fixator is between 1N and 5N.

[0034] The beneficial effects that can be obtained by the technical solution proposed in the present invention include:

[0035] (1) The magnesium metal of the present invention is composed of pure magnesium, low-alloyed magnesium-zinc alloy or magnesium-zinc-calcium alloy, with an alloy element mass fraction of 0-3% and an impurity content of ≤0.1%. The magnesium metal is processed into a strip-shaped implanted wire with a width and thickness of 0.1-0.3 mm or a filament-shaped implanted wire with a diameter of 0.1-0.3 mm, and the degradation rate is controllable. In simulated body fluid, the degradation rate is not less than 1.5 mm / year and not more than 10 mm / year, and the implanted wire can be completely degraded within two weeks. The degradation product is alkaline and will not cause aseptic inflammatory reaction.

[0036] (2) The method for preparing the magnesium metal buried wire described in the present invention is extrusion, rolling, laser cutting, molding, or extrusion, drawing, annealing, and weaving; all of which are commonly used process technologies and can achieve large-scale production.

[0037] (3) The surface of the magnesium metal embedded wire described in the present invention can be processed with a barb structure to enhance its grip on soft tissue and reduce the probability of embedded wire displacement and dislocation.

[0038] (4) The integrated thread embedding needle and the assembly method thereof described in the present invention can eliminate the steps of on-site thread installation and wire cutting, thereby improving the efficiency of surgical operation and reducing the psychological burden on patients.

[0039] (5) The magnesium metal wire embedding system of the present invention can implant a specific length of wire according to the treatment cycle requirements to achieve the effect of controlling degradation. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a front view of the integrated wire embedding tool of the present invention.

[0041] Figure 2 This is a partial enlarged view of the fixer fixing the fixing part of the degradable embedded thread to the outer wall of the needle tube.

[0042] Figure 3 It is an assembly diagram of the degradable thread embedding tool of the present invention.

[0043] Figure 4The front view of the strip-shaped degradable buried thread of Example 1..

[0044] Figure 5 The assembly drawing of the strip-shaped degradable buried thread of Example 1.

[0045] Figure 6 The schematic diagram of the filamentous degradable buried thread of Example 2.

[0046] Figure 7 The assembly drawing of the strip-shaped degradable buried thread of Example 2. Detailed implementation manners

[0047] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0048] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "one side", "one end", "one side", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, in the description of the present invention, unless otherwise stated, the meaning of "a plurality" is two or more.

[0049] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0050] It should also be understood that the terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. As used in the specification of the present invention and the appended claims, unless the context clearly indicates otherwise, the singular forms of "a", "an", and "the" are intended to include the plural forms.

[0051] It should also be further understood that the term "and / or" used in the specification and appended claims of the present invention refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0052] Schematic diagrams of various structures according to the disclosed embodiments of the present invention are shown in the drawings. These drawings are not drawn to scale, where certain details are enlarged for the purpose of clear expression, and certain details may be omitted. The shapes of various regions and layers shown in the drawings, as well as their relative sizes and positional relationships, are merely exemplary. In practice, there may be deviations due to manufacturing tolerances or technical limitations, and those skilled in the art can design regions / layers with different shapes, sizes, and relative positions according to actual needs.

[0053] As Figure 1 shown, the integrated buried line tool of the present invention is characterized by comprising a handle 1, a needle tube 2, a degradable buried line 3, and a fixator 4. One end of the needle tube 2 is connected to the handle 1, and the other end of the needle tube 2 penetrates through the fixator 4. One end of the degradable buried line 3 is inserted into the needle tube 2, and the other end is placed outside the needle tube 2 and is wrapped by the fixator 4 outside the needle tube 2.

[0054] Combined Figure 2 shown, one end of the needle tube 2 is connected to the handle 1 by a conventional method. The end of the needle tube 2 away from the handle 1 is provided with a needle tip 21 and a needle tip opening 22. An accommodation space 23 communicating with the needle tip opening 22 is provided inside the needle tube 2.

[0055] The part of the degradable buried line 3 placed outside the needle tube 2 accounts for 30% - 50% of the total length of the degradable buried line, so as to form a fixing part 31 and a bending part 32. The fixing part 31 is wrapped by the fixator 4 on the outer wall 24 of the needle tube 2. The bending part 32 forms an arc, and the bending part 32 is located at the needle tip opening 22. The bending part can play a role in hooking tissues and preventing displacement after the degradable buried line 3 is buried into the acupoint. Preferably, the diameter of the bending part 32 is 0.05 - 0.5 mm. If the diameter is too large, the bending part 32 will cause greater resistance and pain when the needle tube 2 penetrates the skin. On the contrary, if the diameter is too small, the degradable buried line 3 will break at the bending part 32 when the needle tube 2 penetrates the skin.

[0056] Preferably, the material of the degradable buried wire 3 is magnesium or a magnesium alloy with an impurity content of less than or equal to 0.1%, and the magnesium alloy is a low-alloyed magnesium-zinc alloy or a magnesium-zinc-calcium alloy, wherein the mass fraction of the alloying elements is 0 to 3%. The tensile strength of the degradable buried wire 3 is greater than or equal to 150MPa and does not exceed 300MPa, the yield strength is greater than or equal to 80MPa and does not exceed 250MPa, the elongation after fracture is greater than or equal to 5%, the cross-sectional shrinkage is greater than or equal to 5%, and the hardness is less than or equal to 60HV0.1. Too high strength or too high hardness will cause a strong foreign body sensation and pain after the magnesium buried wire is implanted, and the risk of displacement in the body is higher; and the magnesium wire is difficult to deform during the subsequent assembly and shaping process, and the bending portion 32 is easy to break.

[0057] Preferably, the length of the degradable buried thread 3 is 1-10cm, and the width and thickness are 0.1-0.3mm. Furthermore, preferably, the degradable buried thread 3 is strip-shaped or filament-shaped, but not limited thereto. The cross-section of the strip-shaped degradable buried thread 3 is rectangular, and its length and width are both 0.1-0.3mm. The length of the rectangle is the thickness of the strip-shaped degradable buried thread, and the width of the rectangle is the width of the degradable buried thread 3; the cross-section of the filamentary degradable buried thread is circular, and its outer diameter is 0.1-0.3mm. The material and size of the degradable buried thread 3 are designed so that it can be completely degraded after being immersed in SBF simulated body fluid for two weeks, and the degradation rate is not less than 1.5mm / year and not more than 10mm / year. Preferably, the degradation rate is not less than 3mm / year and not more than 5mm / year. If the degradation rate is too fast, it will cause excessive local alkalinity or gas accumulation to cause adverse reactions in the body; if the degradation rate is too slow, the previously implanted degradable buried thread cannot be completely degraded during the next course of treatment.

[0058] The fixer 4 includes an insertion end 41 and an exit end 42 corresponding to the insertion end 41, wherein the insertion end 41 is far from the needle tip 21 and the exit end 42 is close to the needle tip 21. The fixer 4 wraps and fixes the fixing part 31 of the degradable embedded suture to the outer wall 24 of the needle tube 2.

[0059] Preferably, the fixture 4 is made of a polymer material with a Shore A hardness of 10 to 40, such as silicone, polyurethane, etc., but not limited thereto. The length of the fixture 4 along the direction of the needle tube 2 is not less than 3 mm.

[0060] The invention discloses a method for preparing a strip-shaped degradable embedded wire, which is characterized by comprising extrusion casting and rolling forming.

[0061] The extruded ingot is a magnesium or magnesium alloy ingot with an impurity content of less than or equal to 0.1% that is extruded into a plate with a thickness not exceeding 4 mm and a width not exceeding 120 mm.

[0062] The rolling forming is carried out by an isothermal online heating rolling method, rolling into a 0.1-0.3 mm thick thin plate through 8-16 passes, and then completely annealing at 300° C. to 350° C. and then laser cutting or die stamping to form a strip-shaped degradable buried wire with a length of 1 to 10 cm. The cross-section of the strip-shaped degradable buried wire is a rectangle, and the length and width of the rectangle are both 0.1 to 0.3 mm.

[0063] The present invention relates to a method for preparing a filamentous degradable embedded catgut, which is characterized by comprising:

[0064] Extrusion ingot, extruding magnesium or magnesium alloy ingots with impurity content less than or equal to 0.1% into wires with a diameter not exceeding 2mm;

[0065] Drawing filaments, after more than 40 drawing passes and annealing between passes, the average grain size is not more than 50 microns and the diameter is 0.05-0.3mm.

[0066] Embedding thread shaping: at least one of the embedded thread filaments is cleaned, cut and shaped to finally form a filamentous degradable embedded thread with a length of 1-10 cm and a cross-sectional diameter of 0.1-0.3 mm.

[0067] In addition, Figure 3 The present invention also relates to an assembly method of an integrated wire embedding tool, which is characterized by comprising:

[0068] Install the needle tube 2, and insert the end of the needle tube 2 away from the needle tip 21 into the handle 1;

[0069] Insert the degradable embedded thread 3, insert one end of the degradable embedded thread 3 into the accommodating space 23 of the needle tube through the needle tip opening 22, and pre-bend the other end of the degradable embedded thread 3 toward the direction of the handle 1 to form a pre-bent portion;

[0070] The fixator 4 is installed, and the needle tip 24 of the needle tube 2 is inserted from the insertion end 41 of the fixator 4 and passed out from the passing-out end 42 of the fixator; the fixator 4 wraps and fixes the fixing part of the degradable embedded thread to the outer wall 24 of the needle tube 2, and the pre-bent part passes out from the passing-out end 42 of the fixer to form the bent part 32.

[0071] Preferably, the puncture resistance of the needle tube equipped with the degradable embedded thread when passing through the fixture is between 1N and 5N. The diameter of the bent portion 32 is determined by the puncture resistance, and the puncture resistance is affected by the length and hardness of the fixture 4. When the hardness of the fixture 4 is small or the length is short, the puncture resistance is small and the diameter of the bent portion 32 is large, otherwise the diameter is small.

[0072] When the integrated catgut embedding tool of the present invention is in use, first select the integrated catgut embedding tool equipped with the required catgut embedding length. Then, the user holds the handle 1 and inserts the needle tip 21 into the skin to the designated acupoint. At this time, the catgut should be completely inserted into the skin. Finally, the needle tube and the fixator are withdrawn from the skin. The degradable catgut 3 hooks the skin tissue through the arc formed by the bending part 32. Thereby, the degradable catgut detaches from the needle tube 2 and the fixator 4 and remains in the skin, completing the catgut embedding at the designated acupoint. Specific Embodiment

[0074] The technical means of the present invention will be further elaborated through specific embodiments below.

[0075] Embodiment 1

[0076] In this embodiment, the material of the degradable catgut 3 is a magnesium-zinc-calcium alloy, in which the mass fraction of zinc is 1.5% and the mass fraction of calcium is 0.5%. The magnesium-zinc-calcium alloy ingot is extruded to obtain a plate with a thickness of 4 mm and a width of 100 mm. Through the isothermal online heating rolling process, it is rolled into a thin plate with a thickness of 0.3 mm after 12 passes. After complete annealing at 300 °C - 350 °C, the average grain size is 15 microns. After laser cutting, a strip-shaped degradable catgut with a width of 0.3 mm, a thickness of 0.3 mm, and a length of 10 mm is formed. The tensile strength is 262 MPa, the yield strength is 204 MPa, the elongation after fracture is 23.7%, the reduction of area is 30%, and the microhardness is 52.1 HV0.1. In this embodiment, as Figure 4 shown, barbs 33 are cut on the surface of the strip-shaped degradable catgut by laser cutting. The barbs 33 can prevent the degradable catgut 3 from shifting and sliding after implantation.

[0077] The degradable catgut of this embodiment is immersed in SBF simulated body fluid and completely degrades in 13 days, with a degradation rate of 2.07 mm / year. The pH value of the solution rises from the initial 7.4 to 7.96.

[0078] In this embodiment, the handle 1 adopts an anti-slip design and is composed of a cylinder and strip-shaped protrusions evenly distributed on the outer side of the cylinder. The middle of the protrusion part is concave, which is convenient for holding and increases the friction. A support is provided at the front end of the handheld part of the handle 1, which is convenient for installing a plastic protective sleeve to protect the needle tube 2, and the length of the handheld part does not exceed half of the overall length of the integrated catgut embedding tool of the present invention

[0079] In this embodiment, the needle tube 3 is a hollow stainless steel needle tube, and the outer wall 24 surface of the needle tube 3 is laser-etched with scale marks for observing the catgut embedding depth.

[0080] After the strip-shaped degradable catgut 3 in this embodiment is inserted into the needle tube 2, 5 mm of the degradable catgut is placed outside the needle tube.

[0081] In a preferred embodiment of the present invention, the fixator 4 is a cylinder with a diameter of not less than 2 mm. As Figure 5 shown, the fixator 4 in this embodiment is a cylinder with a diameter of 2 mm and a height of 3 mm, and the fixator is made of polyurethane with a Shore hardness of A20; in this embodiment, the puncture resistance of the needle tube 2 passing through the fixator 4 is 1.6 N, and the diameter of the bending part 32 is 0.3 mm.

[0082] After the integrated thread embedding tool of this embodiment is assembled, a puncture experiment is carried out using an acupuncture skin model. The degradable buried thread 3 does not break in the high-resistance area and low-resistance area of the model. The arc structure of the bending part 32 can make the degradable buried thread 3 hook the skin model, and the skin will not be pulled out when the needle is withdrawn.

[0083] Embodiment 2

[0084] As Figure 6 shown, in this embodiment, the degradable buried thread 3' is woven from two buried thread filaments with a magnesium content greater than 99.9% and a cross-sectional diameter of 0.1 mm. The cross-sectional diameter of the degradable buried thread 3 is 0.2 mm and the length is 20 mm. The preparation method of the degradable buried thread 3' is as follows:

[0085] The pure magnesium ingot is extruded twice to obtain a wire with a diameter of 1 mm. After 36 passes of room temperature drawing and intermediate annealing processes, a magnesium wire with a diameter of 0.1 mm is obtained. After full annealing, a buried thread filament with an average grain size of 10 microns is formed. The tensile strength of the buried thread filament is 182 MPa, the yield strength is 114 MPa, the elongation after fracture is 5.2%, the reduction of area is 6%, and the microhardness is 35.3 HV0.1. Two buried thread filaments with a diameter of 0.1 mm are woven clockwise into a filamentous degradable buried thread with a diameter of 0.2 mm, and after cutting, a degradable buried thread 3' with a length of 20 mm is formed.

[0086] The handle 1 and the needle tube 2 in this embodiment are the same as those in Embodiment 1.

[0087] The degradable buried thread 3' is immersed in SBF simulated body fluid and completely degrades in 4 days, and the degradation rate is 4.5 mm / year. The pH value of the solution rises from the initial 7.4 to 8.17.

[0088] As Figure 7As shown, the filamentous degradable embedding thread 3' of this embodiment is inserted into the syringe needle 2, where the length of the degradable embedding thread 3' exposed outside is 10 mm. Then, the fixing part 31' of the degradable embedding thread 3' is wrapped and fixed on the outer wall 24 of the syringe needle 2 by a cylindrical fixator 4' with a diameter of 3 mm and a height of 5 mm. The fixator 4' is made of silicone material with a Shore hardness of A30. The puncture resistance of the syringe needle 2 passing through the fixator is 2.4 N, and the diameter of the formed bent part 32' is 0.15 mm. After the integrated embedding tool is assembled, a puncture experiment is carried out using an acupuncture skin model. The degradable embedding thread 3' does not break in the high-resistance area and low-resistance area of the model, and the bent part 32' can hook the degradable embedding thread to the skin model, and it will not be pulled out of the skin when the needle is withdrawn.

[0089] The advantages of the present invention are as follows:

[0090] (1) The magnesium metal described in the present invention has a composition of pure magnesium, low-alloyed magnesium-zinc alloy or magnesium-zinc-calcium alloy, the mass fraction of alloying elements is 0-3%, and the impurity content is ≤0.1%. The strip-shaped degradable embedding thread or filamentous degradable embedding thread with a width and thickness of 0.1-0.3 mm processed from this component of magnesium metal has a controllable degradation rate, and the degradation rate in simulated body fluid is not less than 1.5 mm / year and does not exceed 10 mm / year, and it can be completely degraded within two weeks. The degradation product is alkaline and will not cause an aseptic inflammatory reaction.

[0091] (2) The preparation method of the magnesium metal embedding thread described in the present invention is extrusion, rolling, laser cutting, molding, or extrusion, drawing, annealing, weaving; all are common process technologies and can achieve large-scale production.

[0092] (3) The magnesium metal embedding thread described in the present invention is provided with a bent part that can hook the skin of the designated acupoint, and the surface of the degradable embedding thread can be processed with barbs to enhance its holding force on soft tissues and reduce the probability of embedding thread displacement and prolapse.

[0093] (4) The integrated embedding needle and its assembly method described in the present invention can eliminate steps such as on-site threading and wire cutting, improve the surgical operation efficiency, and reduce the psychological burden of patients.

[0094] (5) The magnesium metal embedding thread system described in the present invention can implant a specific length of embedding thread according to the requirements of the treatment cycle to achieve the effect of controlling degradation.

[0095] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed above with the preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications to equivalent embodiments of equivalent changes within the scope of the technical solution of the present invention by using the above-disclosed technical content. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. An integrated wire embedding tool, characterized in that: include: handle; A needle tube having an accommodating space inside, one end of the needle tube being connected to the handle, and the other end being provided with a needle tip and a needle tip opening communicating with the accommodating space; A degradable embedded thread, the material of which is magnesium or magnesium alloy; one end of the degradable embedded thread is inserted into the accommodating space of the needle tube through the needle tip opening, and the other end of the degradable embedded thread is placed outside the needle tube; A fixer, the needle tube passes through the fixer, and the degradable embedded thread is wrapped by the fixer on the outside of the needle tube.

2. The integrated wire embedding tool according to claim 1, characterized in that: The degradable buried thread forms a bending portion at the needle tip opening, and the bending portion is arc-shaped with a diameter of 0.05-0.5 mm.

3. The integrated wire embedding tool according to claim 2, characterized in that: The width of the degradable buried thread is 0.1-0.3 mm, and the thickness is 0.1-0.3 mm.

4. The integrated wire embedding tool according to claim 2, characterized in that: The portion of the degradable buried thread outside the needle tube accounts for 30% to 50% of the total length of the degradable buried thread.

5. The integrated wire embedding tool according to claim 2, characterized in that: The fixator is made of a polymer material with a Shore hardness of 10 to 40, has a length of 3 mm to 10 mm along the needle tube direction, and a diameter of not less than 2 mm to 5 mm.

6. The integrated wire embedding tool according to claim 2, characterized in that: The surface of the degradable embedded thread is provided with barbs.

7. The integrated wire embedding tool according to any one of claims 1 to 6, characterized in that: The degradation rate of the degradable buried thread is greater than or equal to 1.5 mm / year and less than or equal to 10 mm / year.

8. The integrated wire embedding tool according to any one of claims 1 to 6, characterized in that: The degradable buried wire has a tensile strength of greater than or equal to 150 MPa and less than or equal to 300 MPa, a yield strength of greater than or equal to 80 MPa and less than or equal to 250 MPa, a fracture elongation of greater than or equal to 5%, a cross-sectional shrinkage of greater than or equal to 5%, and a hardness of less than or equal to 60 HV0.

1.

9. The integrated wire embedding tool according to claim 7, characterized in that: The degradable buried wire has a tensile strength of greater than or equal to 150 MPa and less than or equal to 300 MPa, a yield strength of greater than or equal to 80 MPa and less than or equal to 250 MPa, a fracture elongation of greater than or equal to 5%, a cross-sectional shrinkage of greater than or equal to 5%, and a hardness of less than or equal to 60 HV0.

1.

10. A method for preparing the degradable buried wire in the integrated buried wire tool as claimed in claims 1 to 9, characterized in that: include: Extrusion ingots: extruding magnesium or magnesium alloy ingots with an impurity content of 0.1% or less into plates with a thickness not exceeding 4 mm and a width not exceeding 120 mm; The rolling forming is carried out by an isothermal online heating rolling method, and the thin plate is rolled into a thickness of 0.1 to 0.3 mm through 8 to 16 passes. After complete annealing at 300°C to 350°C, the strip-shaped degradable buried wire with a width of 0.1 to 0.3 mm, a thickness of 0.1 to 0.3 mm, and a length of 1 to 10 cm is formed by laser cutting or die stamping.

11. The preparation method according to claim 10, characterized in that: The mass fraction of alloy elements in the magnesium alloy is 0-3%.

12. A method for preparing the degradable buried wire in the integrated buried wire tool according to claims 1 to 9, characterized in that: include: Extrusion ingot, extruding magnesium or magnesium alloy ingots with impurity content less than or equal to 0.1% into wires with a diameter not exceeding 2mm; Drawing the filaments, after more than 40 drawing passes and annealing between passes, the buried wire filaments with a diameter of 0.05 to 0.3 mm are obtained; Embedding thread shaping: at least one of the embedded thread filaments is cleaned, cut and shaped to finally form a filamentous degradable embedded thread with a length of 1-10 cm and a cross-sectional diameter of 0.1-0.3 mm.

13. A preparation method according to claim 11, characterized in that: In the embedding wire forming stage, two or more embedded wire filaments that have been cleaned and cut are twisted or woven to form a filamentary degradable embedded wire with a length of 1-10 cm and a cross-sectional diameter of 0.1-0.3 mm.

14. The preparation method according to claim 12 or 13, characterized in that: The mass fraction of alloy elements in the magnesium alloy is 0-3%.

15. A method for assembling the integrated wire embedding tool as claimed in claims 1 to 9, characterized in that: include: Install the needle tube, and insert the end of the needle tube away from the needle tip into the handle; Inserting the degradable embedded thread, inserting one end of the degradable embedded thread into the accommodating space of the needle tube through the needle tip opening, and pre-bending the other end of the degradable embedded thread toward the direction of the handle to form a pre-bent portion; The fixator is installed, and the needle tip of the needle tube is inserted from the insertion end of the fixator and passed out from the exit end of the fixator, and the insertion end and the exit end are correspondingly arranged; the fixator wraps the degradable embedded thread on the outside of the needle tube, and the pre-bent portion passes out from the exit end of the fixator to form the bent portion.

16. The assembly method according to claim 15, characterized in that: The puncture resistance of the needle tube equipped with the degradable embedded thread when passing through the fixator is between 1N and 5N.

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